Associate VP, Quality Data Management and Performance

  
Assistant Vice President, Clinical Development Group Lead
 
Sun Pharmaceutical Industries Inc. (Sun Pharma) is the fourth largest specialty generic pharmaceutical company in the world with global revenues of over $ 5 billion US Dollars. Supported by more than 40 manufacturing facilities, we provide high-quality, affordable medicines, trusted by healthcare professionals and patients, to more than 100 countries across the globe including the United States. Sunology is a combination of Sun Values and Ideology and is the way of life at Sun Pharma. Sunology is Humility. Integrity. Passion. Innovation. It represents our promise to all stakeholders including patients, physicians, and employees.
 
Description:
 
Sun is seeking an Assistant Vice President, Group Lead within its Clinical Development organization in Princeton, NJ. The AVP will report into the VP, Head of Clinical Development.
 
 
Responsibilities :
Functional leadership and guidance of a team of clinical professionals including study directors (Asset Leads), medical monitors, and clinical scientists charged with guiding clinical development and subsequent regulatory submissions for all portfolio programs.
Oversee and contribute to clinical development strategy and activities for all portfolio programs to ensure alignment with the company’s overall goals and objectives.
Oversee and participate in the design and planning, execution, and management of clinical trials to evaluate the safety and efficacy of investigational products
Provide broad drug development and functional knowledge and experience and overall clinical scientific leadership for the clinical portfolio including direct responsibility for clinical development strategy, design, and oversight of clinical trials.
Provide recommendations and insights regarding study feasibility and operational risks and challenges based on knowledge of the field and through direct contact with key opinion leaders, potential investigators, patient advocacy groups, and advisory boards.
Support the design and implementation of clinical protocols, data collection systems, digital tools, and data analysis including statistical analyses.
Oversee the analysis and interpretation of clinical trial data, ensuring accurate and meaningful results.
Provide support for interactions with external development partners, investigator meetings, and advisory boards, regulatory authorities, and data monitoring boards.
Collaborate with Medical Affairs and Commercial Teams to develop a strong group of Key Opinion Leaders.
Provide support for internal cross-functional interactions with study teams, including research and development, regulatory affairs, medical affairs, and commercial teams
Provide support for study team and Asset Lead presentations to Global Development leadership and governance to ensure that clinical trials are conducted in compliance with regulatory requirements, guidelines, and industry best practices.
Support study teams to manage clinical development budgets and resources effectively, optimizing timelines, costs, and quality.
Support, review, and be accountable for clinical sections of regulatory documents such as Investigators' Brochures, briefing books, safety updates, IND/BLA submission documents, and responses to Health Authorities questions.
Collaborate across multiple internal multidisciplinary functions including prioritization of internal and external activities based on impact and strategic goals.
Support implementation of initiatives and program-level activities such as SOP development and revision, and portfolio-wide regulatory and compliance requirements.
Ability to be productive and successful and serve as an effective change agent in an intense, fast-paced, and dynamic environment.
Foster a team culture that promotes continuous improvement, ownership, professional growth, and inclusion.
 
Qualifications:
 
~ MD, or MD/PhD
~10+ years of biotech and/or pharma drug experience
~ Successfully conducted clinical development from Phase 1 through registrational Phase 3 studies
~ Demonstrated ability to develop unique and innovative clinical strategies to significantly shorten the development cycle in the face of an evolving regulatory landscape.
~ Experience designing and developing smaller, yet robust and innovative platform trials, randomized Phase 2 and registrational Phase 3 programs.
~ Prior experience interacting effectively and successfully with regulatory agencies is essential, across the spectrum on FIH/IND, End of Phase 2/ pre-Phase 3 and (s)NDA/(s)BLA.
~ Solid knowledge of compliance and global regulatory requirements (ICH) for development of pharmaceutical candidates / products is required. Has working knowledge of GCP, ICH, US FDA and EMEA regulations
~ Proven ability to represent the Company’s interests effectively in interactions with external partners, investigators, and regulatory agencies.
~ Ability to lead a dynamic group in a fast-paced and hands-on environment.
~ Strong consensus-building skills and the ability to lead multi-disciplinary teams towards sound decision-making across various development functions.
~ Outstanding leadership and management capabilities to motivate and guide a strong Clinical Development team.
~ Excellent scientific standing among peers and the ability to address issues with scientific rigor and creative solutions and understanding of pre-clinical development.
~ Experience in working with external collaborators, including CROs, national institutes, and multinational pharmaceutical companies is preferred.
~ Strong analytical and problem-solving skills, is well organized and has mastered complex medical/clinical development tasks
~ Superior written and verbal communication skills within scientific presentation, corporate presentation, and clinical team and clinical trial environments
~ Works effectively under pressure and has a rigorous work ethic with a focus on details and high-quality results
~ Ability to work in matrix environment (dotted-line authority), and lead by influence.
~ Able to assess human resource needs and suggest appropriate prioritizations
~ Clinical Development Experience: Extensive experience in clinical research and drug development, including hands-on experience managing clinical trials, that enables both attention to detail and a broad drug development mindset.
~ Leadership Skills: Strong leadership and team management skills, with a track record of effectively leading cross-functional teams.
~ Regulatory Knowledge: In-depth understanding of global regulatory requirements for clinical trials and drug development.
~ Strategic Thinking: Ability to develop and execute clinical development strategies aligned with business goals.
~ Analytical Skills: Proficiency in analyzing clinical trial data and making data-driven decisions.
~ Problem-Solving: Strong problem-solving and decision-making capabilities, with the ability to navigate complex challenges.
~ Industry Awareness: Stay current with industry trends, emerging therapies, and advancements in clinical trial methodologies.
~ Interpersonal Skills: Collaborative and able to build strong relationships with internal teams and external partners.

 
Actual base compensation may vary based on a number of factors, including but not limited to geographical location and experience. In addition, this position is part of the Annual Performance Bonus Plan. Employees are eligible to participate in Company employee benefit programs which include medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; and the employee assistance program. Employees also receive various paid time off benefits, including vacation time and sick time.
 
The compensation and benefits described above are subject to the terms and conditions of any governing plans, policies, practices, agreements, or other materials or documents as in effect from time to time, including but not limited to terms and conditions regarding eligibility. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company, or individual department/team performance, and market factors.
 
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of the incumbent(s).
 
We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.